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Clinical Trials/ISRCTN42318360
ISRCTN42318360
Completed
Not Applicable

The efficacy of the combination of allergen vaccination and vitamin D3 in the reduction of allergen-specific nasal responses. A placebo controlled trial.

Academic Medical Centre (AMC) (Netherlands)0 sites90 target enrollmentJanuary 9, 2006
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ConditionsRhinitisRespiratoryVasomotor and allergic rhinitis

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Rhinitis
Sponsor
Academic Medical Centre (AMC) (Netherlands)
Enrollment
90
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 9, 2006
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Academic Medical Centre (AMC) (Netherlands)

Eligibility Criteria

Inclusion Criteria

  • •1\. Patients with rhinoconjunctivitis with or without mild asthma for at least 2 years. Their allergic symptoms should be related to the grass\-pollen season.
  • •2\. A positive skin prick test for grass, minimally HEP 1
  • •3\. Positive reaction to intranasal challenge with grass\-pollen
  • •4\. Age between 18 and 65
  • •5\. Patients with a written informed consent
  • •Note: Patients with concomitant sensitisation to perennial allergens like house dust mite and pets can be included as long as they do not reveal clinical symptoms or only at very rare occasional exposure. In case of sensitisation to pets, these pets should not be present at home.

Exclusion Criteria

  • •1\. Use of corticosteroids (systemic and local) outside grass\-pollen season (May\-July)
  • •2\. Serious immunopathologic diseases or malignancies (including auto\-immune diseases, tuberculosis)
  • •3\. Severe asthma or emphysema, based on questionnaire; use of inhaled corticosteroids
  • •4\. Chronic symptoms related to concomitant sensitisation to other perennial allergens like pets or mites
  • •5\. Symptomatic coronary heart diseases or severe (even under treatment) arterial hypertension
  • •6\. Diseases with a contra\-indication for the use of adrenaline
  • •7\. Severe kidney disease
  • •8\. Treatment with beta\-blockers or ACE inhibitors or immunosuppressive drugs
  • •9\. Severe atopic dermatitis
  • •10\. Immunotherapy (including sublingual) treatment with grass\-pollen within the last 5 years

Outcomes

Primary Outcomes

Not specified

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